Umbilical cord clamp and cutter

ABSTRACT

A novel umbilical cord clamp and a combined umbilical cord clamp and cutter are provided for clamping and cutting umbilical cords in one motion. The cutter comprises two shells joined by a longitudinal hinge. A transverse blade is mounted in one shell, and a cutting support is mounted in the other shell across from the blade. One or more removable clamps may be engaged with the shells to be removable from the shells after cutting. Alternatively, a self-winding or plastically deformable band may be engageable with the shells. The cutter and its associated removable clamp(s) may be coordinated with an identifier, such as a color, number, or letter. Blood sampling and diagnostic features may be included with the cutter. The removable clamps may have an openable closure.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 10/232,029 filed Aug. 30, 2002, now U.S. Pat. No. 6,740,095,which is a continuation of U.S. patent application Ser. No. 09/874,770filed Jun. 5, 2001, now U.S. Pat. No. 6,443,958, each of which isincorporated herein by reference. This application also claims thebenefit of U.S. Provisional Patent Application No. 60/424,776 filed Nov.8, 2002, which is incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates generally to umbilical cord clamps and cutters,and more particularly to a combined umbilical cord clamp and cutter forclamping and cutting an umbilical cord in one continuous motion.

2. Description of the Related Art

A number of clamps and cutters are known in the art for clamping andcutting the umbilical cords of newborn babies. Perhaps the most commonclamp currently used for such purposes is the umbilical cord clampdisclosed in U.S. Pat. No. 4,212,303, issued to Nolan on Jul. 15, 1980and assigned to Hollister Incorporated (“the Hollister clamp”). TheHollister clamp comprises a pair of flexible arms joined by an integralhinge to form a generally V-shaped clamp. The interior of each arm hasserrations or ridges for grasping the umbilical cord. The free end ofone of the arms has a flexible tongue that cooperates with a recess onthe free end of the other arm to close the clamp about the umbilicalcord. In practice, two Hollister clamps are clamped to the umbilicalcord in spaced relation to one another, and the cord is then cut betweenthe two clamps using scissors or a scalpel. One clamp is temporarilyleft on the baby's navel, and the other clamp is disposed of with theplacenta. The Hollister clamp has several drawbacks. First, it takesthree separate instruments (two clamps and a cutting tool) to accomplishthe process of cutting the umbilical cord using the Hollister clamp. Inan alternative practice, one Hollister clamp is frequently used inconjunction with a hemostat, and the cord is cut between the Hollisterclamp and the hemostat. If a hemostat is used instead of a secondHollister clamp during the cutting process, the overall procedure iseven more cumbersome because the hemostat is typically replaced with asecond Hollister clamp after the cord is cut, which adds a fourthinstrument. Second, the Hollister clamp does not provide any shield fromthe splatter of blood when the umbilical cord is cut, which presents adanger of blood-borne pathogens to hospital personnel. Additionally, theHollister clamp is not aesthetically attractive when left on the baby'snavel.

Several combined clamp and cutter devices have been developed thatessentially employ the Hollister clamp. An example of one such device isshown in U.S. Pat. No. 5,925,052, issued to Simmons on Jul. 20, 1999(“Simmons”). Simmons discloses a scissor-type device with a cuttingblade that receives an assembly comprising a pair of Hollister-typeclamps. As the scissors are squeezed together, the blade severs theumbilical cord and the clamp assembly while closing the two clamps oneither side of the cut. Although the Simmons device combines the twoclamps and cutter into a single tool, it does not solve the problem ofthe need for a shield to guard against the splatter of blood nor theproblem of poor aesthetics. A similar device is also disclosed in U.S.Pat. No. 5,968,054, issued to Yeatts et al. on Oct. 19, 1999, whichsuffers from the same disadvantages.

U.S. Pat. No. 5,697,938, issued to Jensen et al. on Dec. 16, 1997(“Jensen”), discloses a disposable device for squeezing and cutting anumbilical cord comprising a pair of clamps that mate with a sliding unitwhich contains a blade. As the sliding unit closes the clamps, the bladesevers the umbilical cord. Again, however, the Jensen device does nothave a shield to prevent the splatter of blood, and the clamps aremodifications of the Hollister clamp which are not aestheticallyappealing.

U.S. Pat. No. 5,676,672, issued to Watson et al. on Oct. 14, 1997(“Watson”), addressed the problem of the splatter of blood by housing acutting blade and a circular clamping surface inside a cooperating pairof semi-cylinders joined by a hinge. A similar pair of semi-cylinderswith a second circular clamping surface is connected to the first pairof semi-cylinders with a breakable joint. As the two pair ofsemi-cylinders are closed in clamshell fashion, the clamping surfacescompress the umbilical cord. Thereafter, the blade is depressed to severthe cord, and the semi-cylinders prevent the blood from splattering.Then, the two pair of semi-cylinders are separated by breaking thebreakable joint. The pair of semi-cylinders without the blade is leftwith the baby, and the other pair is discarded with the placenta.Although the Watson device solved the blood splatter problem, the pairof semi-cylinders left with the baby is bulky and aestheticallyunattractive. Additionally, although the Watson device was intended toenable one-handed operation, the Watson device presents significantdifficulties in the process of depressing the blade and breaking theclamps apart.

Thus, a need exists for a disposable umbilical cord clamp and cutterthat prevents the splatter of blood, is easy to operate with one hand,and leaves an aesthetically pleasing clamp on the baby's navel.

As is known in the art, in multi-infant births (i.e., twins, triplets,quadruplets, and so on), the umbilical cords of the various infants arefrequently tangled up, sometimes severely so, which makes keeping trackof the cord (and placenta) associated with each infant a tedious andtime consuming task for delivery personnel. Keeping track of the cordassociated with each infant is important because a particular infant mayhave a blood condition or other characteristic that is not common to theother siblings, and such condition or characteristic typically does notbecome known until after the infants have been separated from theirrespective cords and the cord blood from each cord has been sampled andtested. Therefore, before the cords are cut, great care must be taken toidentify each cord on each side of the cut so that after the cutting ofall the cords it is possible to identify which cord is associated witheach infant. This identification process takes precious time, which isof particular concern because multi-infant births are typically carriedout by Cesarean section. In a Cesarean section operation, the risk ofcomplications increases as the duration of the operation increases.Therefore, it would be a significant advancement in the art to provide asimpler and more efficient means of identification for multi-infantbirths.

Additionally, because immediate treatment of certain blood disorders andother diseases is often required or beneficial following birth, earlydiagnostic information concerning the existence and nature of such blooddisorders and other diseases would be highly advantageous.

Further, an improved, safe, and efficient means of taking cord bloodsamples would also be highly advantageous.

SUMMARY OF THE INVENTION

To solve the problems mentioned above, a cutter device in accordancewith the present invention comprises a pair of shells connected by alongitudinal hinge. The first shell has a transverse blade fixedlymounted therein and a clamping member adjacent the blade on the “mother”side of the blade. The second shell has a cutting support aligned withthe blade. The cutter is positioned with the umbilical cord lying acrossthe cutting support, which preferably comprises a pair of wallsseparated by a gap into which the blade may pass. On the “baby” end ofthe cutter, a removable clamp is inserted between the shells. Theremovable clamp has a clamp body with a corrugated clamping surface, astrap for cooperating with the clamping surface, and a hinge joining thestrap to the clamp body. The clamp body has a crown opposite theclamping surface for engagement with the interior surface of the firstshell, and the exterior surface of the strap engages the interiorsurface of the second shell. Thus, as the two shells are closed, theclamping member in the first shell of the cutter compresses theumbilical cord on the “mother” side of the blade, the clamping surfaceof the removable clamp compresses the umbilical cord against the strapof the removable clamp on the “baby” side of the blade, and the bladesevers the umbilical cord, all in one motion through the action of onehand of the user.

As the umbilical cord is severed as described above, the shellssubstantially surround the cord and thereby prevent the splattering ofblood. Preferably, the clamping member in the first shell has at leastone tab for engagement with a catch extending from the second shell.More preferably, two tabs are provided for engagement with the catch.Together, the tabs and catch constitute a latch to keep the shellsclosed after the cut is complete. Toward the end of the closing of theshells, the first tab clicks into engagement with the catch to indicatethat the shells are prevented from reopening. Upon further squeezing ofthe shells, the second tab clicks into engagement with the catch toindicate that the cut is complete. Also, each shell is preferablyprovided with a guide that engages the guide of the other shell to forma detent that holds the shells in a partially open initial positionbefore the cutting process is begun. The exterior of each shell ispreferably provided with a plurality of protrusions or recesses toassist the user in gripping the cutter. Together, the shells have anoverall outer shape that comfortably fits in the palm of the user'shand.

In the vicinity where the removable clamp is mounted to the shells ofthe cutter, the periphery of each shell is provided with an indentationto allow access to a protrusion of the removable clamp. After theumbilical cord is severed, the user may use a thumb to apply a force tothe protrusion of the removable clamp in order to dislodge the removableclamp from the shells. The removable clamp is then left with the baby,and the cutter is discarded with the placenta. The removable clamp ispreferably shaped like the head of a koala bear, with facial indicia(e.g., eyes, nose, and mouth) on the face. When the removable clamp isengaged with the shells of the cutter, the face of the koala bear istoward the interior of the cutter. After the removable clamp is removedfrom the cutter, the baby is left with a clamp on its navel thatresembles a koala bear, which is much more attractive than a Hollisterclamp. Therefore, the removable clamp of the present invention isaesthetically pleasing as well as very practical. The removable clampmay also be made in the shape of various other animals, such as a teddybear or duck, or other non-animal shapes, such as an ellipse.

In addition, the removable clamp is preferably provided with a recess onthe back side of the clamp body. The recess provides for reduced weightof the clamp and tends to eliminate sink marks if the clamp ismanufactured by a molding process. Also, the recess allows for awireless transmitter to be inserted in the clamp so that the baby can betracked electronically.

It is an object of the present invention to provide a combined umbilicalcord clamp and cutter for clamping and cutting an umbilical cord in onemotion.

It is a further object of the present invention to provide a disposableumbilical cord clamp and cutter that prevents the splatter of blood orother fluids when cutting an umbilical cord.

It is another object of this invention to provide a combined umbilicalcord clamp and cutter that is easily and safely operable with one hand.

It is still another object of this invention to provide an improvedumbilical cord clamp that is aesthetically pleasing.

Further objects and advantages of the present invention will be readilyapparent to those skilled in the art from the following detaileddescription taken in conjunction with the annexed sheets of drawings,which illustrate a preferred embodiment of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an umbilical cord cutter and removableclamp in accordance with the present invention shown in a closedposition.

FIG. 2 is an exploded perspective view of the umbilical cord cutter ofFIG. 1 shown in an open position.

FIG. 3 is another perspective view of the umbilical cord cutter of FIG.1 shown in an open position.

FIG. 4 is yet another perspective view of the umbilical cord cutter andremovable clamp of FIG. 1 shown in an open position without the blade.

FIG. 5 is still another perspective view of the umbilical cord cutterand removable clamp of FIG. 1 shown in an open position without theblade.

FIG. 6 is a front elevational view of the umbilical cord cutter of FIG.1 shown in an open position.

FIG. 7 is a front elevational view of the umbilical cord cutter of FIG.1 shown in a closed position.

FIG. 8 is a top view of the umbilical cord cutter of FIG. 1 shown in anopen position.

FIG. 9 is a sectional view taken along line 9-9 of FIG. 8.

FIG. 10 is a sectional view similar to FIG. 9 but with the umbilicalcord cutter in a closed position.

FIG. 11 is a sectional view taken along line 11-11 of FIG. 8.

FIG. 12 is a sectional view taken along line 12-12 of FIG. 8.

FIG. 13 is a perspective view of the removable clamp of FIG. 1 shown inan open position.

FIG. 14 is a front elevational view of the removable clamp of FIG. 1shown in an open position.

FIG. 15 is a front elevational view of the removable clamp of FIG. 1shown in a closed position.

FIG. 16 is a rear elevational view of the removable clamp of FIG. 1shown in a closed position.

FIG. 17 is a sectional view taken along line 17-17 of FIG. 16.

FIG. 18 is a perspective view illustrating the use of the umbilical cordcutter and removable clamp of FIG. 1.

FIG. 19 is a sectional view similar to FIG. 17 showing displacement ofthe face of the removable clamp.

FIG. 20 is a sectional view taken along line 20-20 of FIG. 15.

FIG. 21 is a perspective view of an alternative umbilical cord cutterwith two removable clamps in accordance with the present invention shownin an open position.

FIG. 22 is a sectional view taken along line 22-22 of FIG. 16.

FIG. 23 is a sectional view taken along line 23-23 of FIG. 16.

FIG. 24 is a sectional view taken along line 24-24 of FIG. 16.

FIG. 25 is a perspective view of another alternative umbilical cordcutter and clamp in accordance with the present invention.

FIG. 26 is an exploded perspective view of the umbilical cord cutter andclamp of FIG. 25.

FIG. 27 is a front elevational view of the clamp of FIG. 25.

FIG. 28 is a perspective view of yet another alternative umbilical cordcutter and clamp in accordance with the present invention.

FIG. 29 is an exploded perspective view of the umbilical cord cutter andclamp of FIG. 28.

FIG. 30 is a front elevational view of the clamp of FIG. 28.

FIG. 31 is a perspective view of still another alternative umbilicalcord cutter and clamp in accordance with the present invention.

FIG. 32 is an exploded perspective view of the umbilical cord cutter andclamp of FIG. 31.

FIG. 33 is a front elevational view of one embodiment of the clamp ofFIG. 31.

FIG. 34 is a front elevational view of another embodiment of the clampof FIG. 31.

FIG. 35 is a front elevational view of yet another embodiment of theclamp of FIG. 31.

FIG. 36 is a perspective view of another alternative umbilical cordcutter with two removable clamps in accordance with the presentinvention shown in an open position.

FIG. 37 is a perspective view of yet another alternative umbilical cordcutter and clamp in accordance with the present invention.

FIG. 38 is a rear elevational view of the cutter of FIG. 37.

FIG. 39 is a top view of yet another cutter with a releasable band inaccordance with the present invention.

FIG. 40 is a side elevational view of a portion of an infant having itsumbilical cord compressed with the band of FIG. 39.

FIG. 41 is a perspective view of still another cutter and with tworemovable clamps in accordance with the present invention.

FIG. 42 is a bottom view of another alternative cutter and clamp inaccordance with the present invention.

FIG. 43 is a front view of the blood collection reservoir of FIG. 42.

FIG. 44 is a top view of the blood collection reservoir of FIG. 43 takenin the direction of arrows 44-44.

FIG. 45 is a front view of an alternative blood collection reservoir inaccordance with the present invention.

FIG. 46 is a bottom view of the blood collection reservoir of FIG. 45taken in the direction of arrows 46-46.

FIG. 47 is a bottom view of still another alternative cutter with tworemovable clamps in accordance with the present invention.

FIG. 48 is a sectional view of a portion of the cutter of FIG. 47 takenin the direction of arrows 48-48.

FIG. 49 is a sectional view of a portion of the cutter of FIG. 47 takenin the direction of arrows 49-49.

FIG. 50 is a front view of yet another alternative blood collectionreservoir in accordance with the present invention.

FIG. 51 is a top view of the blood collection reservoir of FIG. 50 takenin the direction of arrows 51-51.

FIG. 52 is a perspective view of yet another alternative cutter andclamp in accordance with the present invention.

FIG. 53 is a rear elevational view of an alternative umbilical cordclamp in accordance with the present invention.

FIG. 54 is a side elevational view of the clamp of FIG. 53.

FIG. 55 is a partial rear elevational view of an alternative latch forthe clamp of FIG. 53.

FIG. 56 is a rear elevational view of another alternative umbilical cordclamp in accordance with the present invention.

FIG. 57 is a side elevational view of the clamp of FIG. 56.

FIG. 58 is a rear elevational view of still another alternativeumbilical cord clamp in accordance with the present invention.

FIG. 59 is a side elevational view of the clamp of FIG. 58.

FIG. 60 is a partial sectional view of the clamp of FIG. 59 taken in thedirection of arrows 60-60.

FIG. 61 is a perspective view of another alternative umbilical cordcutter with one removable clamp in accordance with the present inventionshown in an open position.

DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT

Referring primarily to FIGS. 1-6, a cutter 10 in accordance with thepresent invention comprises a first shell 12 joined to a second shell 14by a longitudinal hinge 16. Preferably, hinge 16 is integral with shells12 and 14, but shells 12 and 14 could be made separately and joined witha separate hinge. As discussed further below, a removable baby clamp 100is installed on one end of cutter 10. Baby clamp 100 is not shown inFIGS. 2, 3, and 6 for the sake of clarity. A blade 40 is transverselymounted to the inside of shell 12 with a blade holder 30, which extendsfrom the inner surface of shell 12. Blade 40, which is preferably madeof surgical steel about 0.03 in. thick, is not shown in FIGS. 4 and 5for the sake of clarity. The end of cutter 10 to which baby clamp 100 ismounted is referred to as the “baby end,” and the other end is referredto as the “mother end.” As best seen in FIG. 2, blade holder 30preferably comprises two upstanding walls 32 and 34 connected by asupport member 36. Additional support members 38 a and 38 b are providedto stabilize the inner and outer ends of blade 40, and a plurality ofgussets 39 are provided to further strengthen and stiffen blade holder30. Blade 40 contains a slot 42 such that blade 40 straddles supportmember 36. Tooling holes 44 are provided to facilitate the installationof blade 40 by pressing it into blade holder 30.

On the inside of shell 14 opposite blade 40, a cutting support 50 isprovided to support an umbilical cord (not shown) while the cord isbeing cut by blade 40. Cutting support 50 preferably comprises a pair ofupstanding walls 52 separated by a gap 58 into which blade 40 protrudesas the cord is being cut. The width d_(g) of gap 58 (best shown in FIG.8) is preferably about 0.06 in. If width d_(g) is too wide (for example,greater than about 0.125 in.), blade 40 will tend to press the umbilicalcord into gap 58 rather than cut through the umbilical cord. Walls 52preferably have relatively sharp upper edges 56 to help preventlongitudinal movement of the umbilical cord during the cutting process.Buttresses 54 a-d may be provided to strengthen and stiffen walls 52 andto serve as lateral constraints to help prevent excessive lateralmovement of the umbilical cord. The “V” shape of walls 52 also helps tokeep the umbilical cord properly positioned for cutting.

On the mother side of blade 40, a clamping member 20 extendstransversely from shell 12. Preferably, clamping member 20 has aplurality of teeth 26 for engaging the umbilical cord, and clampingmember 20 preferably cooperates with a plurality of ridges 18 formed onthe inside of shell 14 opposite clamping member 20. Ridges 18 may beconnected by a central ridge 19. Clamping member 20 is preferablystabilized by a plurality of gussets 23.

To keep cutter 10 closed after the umbilical cord has been severed, apair of tabs 22, 24 is provided on clamping member 20 for cooperationwith a catch 60 that depends from shell 14. As the cut is beingperformed, first tab 22 will click into engagement with catch 60, whichprevents shells 12 and 14 from accidentally coming open. Thereafter,upon further squeezing of shells 12 and 14, tab 24 will click intoengagement with catch 60 to indicate that the cut has been completed. Inaddition to providing a locking function, the clicking of tabs 22 and 24into engagement with catch 60 provides audible and tactile indicationsto the user that shells 12 and 14 are restricted from reopening and thatthe cut has been completed. An opening 84 is preferably created in shell14 by a protrusion of the mold used to form catch 60. If for some reasoncutter 10 needs to be opened after the umbilical cord has been severed,opening 84 provides access to the interior of cutter 10 so that catch 60may be deflected outward and thereby disengaged from tabs 22 and 24.Alternatively, catch 60 may be accessed for such purpose through theopening between shells 12 and 14 at the mother end of cutter 10. Aplurality of bumps 86, or alternatively depressions, may be provided onshells 12 and 14 to facilitate grasping by the user.

To facilitate installation and removal of baby clamp 100 to and fromcutter 10, slots 74 and 76 are provided on the baby end of shell 12 toform a flexible shelf 66, and slots 78 and 80 are provided on the babyend of shell 14 to form a flexible shelf 68. A plurality of nibs 82 areprovided on shelves 66 and 68 for cooperation with recesses 138 on babyclamp 100, as best shown in FIG. 14, to retain baby clamp 100 on cutter10. Guides 28, 160, and 162 also help to properly position baby clamp100 with respect to cutter 10. Shells 12 and 14 and baby clamp 100 arepreferably sized such that shelves 66 and 68 exert a slight compressiveforce on baby clamp 100 when cutter 10 is in a closed position. Shortfences 70 and 72 are preferably provided just inside shelves 66 and 68,respectively, to prevent baby clamp 100 from sliding too far into theinterior of cutter 10. Indentations 88 and 90 are provided in shells 12and 14, respectively, to facilitate removal of baby clamp 100 after theumbilical cord has been cut by allowing the user to place a thumb behindan ear 128 of baby clamp 100 and dislodge baby clamp 100 from cutter 10.

To hold shells 12 and 14 in a partially open initial position as shownin FIGS. 4 and 5, cooperating guides 62 and 64 are provided on shells 12and 14, respectively. Guides 62 and 64, which preferably have rounded orchamfered nibs 92 that allow initial engagement of guides 62 and 64 andthat cause guides 62 and 64 to bear against one another as shells 12 and14 are closed during the cutting process, serve as a detent to preventshells 12 and 14 from opening up excessively so that cutter 10 may beeasily handled in order to properly position an umbilical cord therein.Such an initial position is also a preferred starting position fromwhich to begin the cutting process. A cutout 65 is provided in shells 12and 14 to accommodate guides 62 and 64 when shells 12 and 14 are closed.

FIGS. 6 and 7 illustrate the relationship of blade 40 to clamping member20 and cutting support 50 in open and closed cutter positions,respectively. As shown in FIG. 6, blade 40 (including the pointed tip ofblade 40) is shallower than imaginary arc 46 of clamping member 20 atall points such that clamping member 20 will begin to engage theumbilical cord before blade 40 does so as cutter 10 is closed.Additionally, the recession of blade 40 below clamping member 20 helpsto prevent medical personnel from being cut while handling cutter 10.Although cutter 10 may be made in any suitable size, in order toaccommodate umbilical cords ranging from about 5 to 20 mm in diameter,the radius of arc 46 is preferably about 0.62 in., the distance S_(c)along arc 46 is preferably about 1.3 in., the depth d_(t) of teeth 26 ispreferably about 0.08 in., the distance S_(t) between successive teeth26 along arc 46 is preferably about 0.22 in., the combined total ofdistances d₁, d₂, d₃, and d₄ is preferably about 1.6 in., and thethickness T_(c) of clamping member 20 (best shown in FIG. 11) ispreferably about 0.05 in. If T_(c) is too thin, clamping member 20 wouldtend to cut the umbilical cord rather than pinch it as desired; if T_(c)is too thick, clamping member 20 would tend to crush the umbilical cord.Almost immediately after clamping member 20 begins to engage theumbilical cord, the blood flow within the umbilical cord begins todecrease as the umbilical cord is constricted and cut. Thisphysiological phenomenon helps to reduce the amount of blood that isavailable to squirt out of the umbilical cord during the cuttingprocess. The blood that does squirt out of the umbilical cord during thecutting process is trapped by shells 12 and 14, which preventssplattering of blood and thereby improves cleanliness of the operatingroom and reduces the risk of blood born diseases to persons in theoperating room. As shown in FIG. 7, blade 40 protrudes all the way pastedges 56 of walls 52 of cutting support 50 to accomplish a clean,complete severance of the umbilical cord. Because blade 40 is shallowerthan clamping member 20 and clamping surface 108, and because edges 56of cutting support 50 are elevated above the interior surfaces of shell14 and strap 104 with which clamping member 20 and clamping surface 108respectively cooperate to compress the umbilical cord on either side ofblade 40, clamping member 20 and clamping surface 108 place theumbilical cord in tension across cutting support 50, which furtherenhances the cutting performance of blade 40 by pulling the cord apartat the cut.

FIGS. 8-10 illustrate the relationship of clamping member 20 to ridges18 and 19 and also the relationship of tabs 22 and 24 to catch 60 andopening 84. As shown in FIG. 8, clamping member 20 is longitudinallyaligned with ridge 19, which is centered on ridges 18. FIGS. 9 and 10show the lateral cross-section of cutter 10 through clamping member 20,ridges 18, and catch 60 with cutter 10 in an open and closed position,respectively. As shown in FIG. 10, in the closed position, tab 24 isengaged with catch 60 to prevent shells 12 and 14 from openinginadvertently, and clamping member 20 is brought to a position in whicha small gap 166 exists between clamping member 20 and shell 14. Theumbilical cord (not shown) is compressed within gap 166 and is heldfirmly in place by teeth 26 and ridges 18. Gap 166 is sized such thatthe umbilical cord is compressed sufficiently so as to completely shutoff the flow of blood within the umbilical cord. Preferably, toaccommodate umbilical cords ranging from about 5 to 20 mm in diameter,gap 166 is sized such that the distance d₅ (from the roots of teeth 26to the interior surface of shell 14) is about 0.15 in., the distance d₆(from the tips of teeth 26 to the interior surface of shell 14) is about0.07 in., and the distance d₇ (from the interior surface of shell 14 tothe tips of ridges 18) is about 0.03 in.

FIG. 11 shows a longitudinal cross-section of shell 12 passing throughclamping member 20, blade holder 30, and fence 70. As seen in FIG. 11,shell 12 preferably has a slight longitudinal curvature as well aslateral curvature for ease in handling. Similarly, FIG. 12 shows alongitudinal cross-section of shell 14 passing through ridges 18, 19,walls 52 of cutting support 50, fence 72, and nub 82. Shell 14preferably has a thickened area 168 in the vicinity of ridges 18, 19 andwalls 52 of cutting support 50 to eliminate the longitudinal curvatureon the interior of shell 14 at ridges 18, 19 so that ridges 18, 19better cooperate with clamping member 20 and to increase the strengthand stiffness of cutting support 50. Like shell 12, shell 14 preferablyhas a slight longitudinal curvature as well as lateral curvature forease in handling.

As shown in FIGS. 13-17, baby clamp 100 comprises a clamp body 102 and astrap 104 connected by a hinge 106. Clamp body 102 preferably has acorrugated clamping surface 108 for clamping the umbilical cord incooperation with the inner surface 122 of strap 104, which preferablyhas a plurality of ridges 124 to help grip the umbilical cord. To saveweight, clamp body 102 preferably has a central cavity 154 bounded byclamping surface 108 and a crown 134. When baby clamp 100 is installedin cutter 10, back surface 158 faces away from cutter 10 (as best shownin FIG. 1) and face 156 faces toward the interior of cutter 10 (as bestshown in FIG. 4). At the end of strap 104 opposite hinge 106, strap 104has an ear 128 with a slot 130 for receiving a hook 110 that dependsfrom clamp body 102 opposite hinge 106. Hook 110 has a catch 112 thatcooperates with a recess 132 (best seen in FIGS. 4 and 5) for holdingbaby clamp 100 in the closed position. The thickness of hook 110preferably varies from about 0.06 in. at dimension d₈ to about 0.04 in.at dimension d₉, and the width W_(L) of hook 110 (best shown in FIG. 20)is preferably about 0.13 in. Hook 110 preferably subtends an angle θ_(L)of about 117 degrees with an inner arc length of about 0.31 in. As shownin FIG. 20, the overall thickness T_(L) of ear 128 and hook 110 ispreferably about 0.09 in. Hinge 106 preferably has an arc length S_(H)of about 0.68 in. Crown 134 and strap 104 preferably have a plurality ofrecesses 138 for cooperating with nubs 82 on shelves 66, 68 to hold babyclamp 100 in cutter 10. Ridges 114 and 136, which depend from clamp body102, cooperate with ridges 120 and 126 of strap 104 to close the gapbetween clamp body 102 and strap 104 in the vicinity of hinge 106 andear 128 when baby clamp 100 is closed. A curved closeout 118 ispreferably provided on the end of strap 104 adjacent hinge 106 to helpprevent the umbilical cord from slipping into hinge 106. For symmetry, asimilar closeout 146 may be provided on ear 128. When baby clamp 100 isclosed, the umbilical cord will lie compressed in the gap 174 betweenstrap 104 and clamp body 102 and will be held firmly in place byclamping surface 108 and ridges 124. To accommodate umbilical cordsranging from about 5 to 20 mm in diameter, radius R _(s) of strap 104 ispreferably about 0.56 in., and distance S_(s) between ridges 120 and 126along the interior surface 122 of strap 104 is preferably about 1.08 in.Tooling holes 140 may be provided to help remove baby clamp 100 from itsmold during manufacturing. The exterior surfaces of crown 134 and strap104 preferably have a plurality of recesses 142 to help the user gripbaby clamp 100. As is readily apparent from the drawings, when babyclamp 100 is closed, a preferred shape of baby clamp 100 resembles thehead of a koala bear. Accordingly, face 156 of clamp body 102 may beprovided with protrusions that form a pair of eyes 148, a nose 150, anda mouth 152. Cavity 154 may also be utilized to house a sensor (notshown) for tracking the location of the baby after baby clamp 100 hasbeen installed.

Preferably, cutter 10 and baby clamp 100 are each molded as a singlepiece of material. Alternatively, cutter 10 and baby clamp 100 may bemachined or manufactured according to other methods known in the art.Although a variety of materials may be used, the preferred material ispolycarbonate, which may be translucent and may be manufactured in avariety of colors. Because cutter 10 is intended to be a disposableproduct, hinge 16 need not be capable of many openings and closings ofshells 12 and 14. The present inventors have found that hinge 16 ispreferably about 0.02 in. thick if polycarbonate material is used. Indescribing the best mode of practicing this invention, a number ofdimensions are disclosed herein for various features of the invention.However, it should be recognized that such dimensions, likepolycarbonate material, are simply preferred, and this invention is notlimited to the dimensions or materials described herein.

In order to accommodate umbilical cords ranging from about 5 to 20 mm indiameter, baby clamp 100 is designed such that clamp body 102 movestoward the interior of cutter 10 during the clamping process. In thatregard, the angle 178 between clamping surface 108 and clamp body 102 ispreferably slightly more than 90 degrees. This obtuse angle 178 alsohelps in removing baby clamp 100 from the mold during manufacturing.Similar to teeth 26 on clamping member 20, the corrugations of clampingsurface 108 also assist in accommodating cords of varying size. As anumbilical cord is being clamped, the upward pressure on clamping surface108 causes torsional displacement of hinge 106 such that the lower edgeof clamp body 102 moves away from strap 104 as shown in FIG. 19. Thisdesign of baby clamp 100 is such that, after the umbilical cord has beencut and baby clamp 100 is left on the infant's navel, pulling of babyclamp 100 in a direction away from the infant generally serves totighten the grip of baby clamp 100 on the stub of the cord, which helpsto prevent inadvertent removal of baby clamp 100 from the infant. Asillustrated in FIG. 20, gaps having a distance d₁₀ of preferably about0.05 in. are provided between ridges 120 and 136 and ridges 126 and 114to allow clamp body 102 to move as hinge 106 flexes. For proper flexure,hinge 106 preferably has a thickness T_(h) of about 0.06 in. and a widthW_(h) of about 0.25 in. As shown in FIGS. 17 and 19, the lower edge ofclamp body 102 preferably has a thickness T_(f) of about 0.08 in. toproperly pinch the umbilical cord. As with clamping member 20 discussedabove, if T_(f) is too thin, clamp body 102 would tend to cut theumbilical cord rather than pinch it as desired; if T_(f) is too thick,clamp body 102 would tend to crush the umbilical cord.

FIGS. 17, 22, 23, and 24 illustrate preferred distances between strap104 and clamp body 102 when baby clamp 100 is in the closed position inorder to snugly clamp umbilical cords ranging from about 5 to 20 mm indiameter. Specifically, distances d₁₁ through d₂₂ preferably have thefollowing approximate dimensions:

d₁₁≈0.08 in.;

d₁₂≈0.06 in.;

d₁₃≈0.11 in.;

d₁₄≈0.04 in.;

d₁₅≈0.06 in.;

d₁₆≈0.07 in.;

d₁₇≈0.12 in.;

d₁₈≈0.05 in.;

d₁₉≈0.15 in.;

d₂₀≈0.03 in.;

d₂₁≈0.04 in.;

d₂₂≈0.06 in.

Distances d₁₁, d₁₄, d₁₇, d₂₀ are average distances from ridges 124 toclamping surface 108 in view of the slight inclination of clampingsurface 108 at angle 178 as discussed above.

The use of cutter 10 and baby clamp 100 in cutting an umbilical cord 164is illustrated in FIG. 18. Umbilical cord 164 is placed in shell 14 sothat umbilical cord 164 is generally centered in the “V” of walls 52 oncutting support 50. Cutter 10 and baby clamp 100 are oriented such thatarrow 170 is toward the mother and arrow 172 is toward the baby. Oncethe umbilical cord 164 is thus placed, shell 12 is rotated about hinge16 toward shell 14, and shelf 66 of shell 12 thereby rotates body 102 ofbaby clamp 100 about hinge 106 toward strap 104, which is supported byshelf 68 of shell 14. As shell 12 approaches shell 14, clamping member20 engages cord 164 on the mother side of blade 40, and clamping surface108 engages cord 164 on the baby side of blade 40. As the closing ofcutter 10 and baby clamp 100 upon cord 164 continues, clamping member 20and ridges 18, 19 (best shown in FIG. 3) firmly clasp cord 164 on themother side of blade 40, and clamping surface 108 and ridges 124 firmlyclasp cord 164 on the baby side of blade 40, which puts cord 164 intension across cutting support 50. In the same closing motion, blade 40severs cord 164 as blade 40 is forced into gap 58 between walls 52 ofcutting support 50. The cutting performance is enhanced by the tensionin cord 164, as discussed above. At the end of the closing motion, tabs22 and 24 successively click into engagement with catch 60 to indicatethat the cut is complete. After completion of the cut, the user removesbaby clamp 100 from cutter 10 by placing his or her thumb 176 in the gapbehind ear 128 formed by indentations 88 and 90 and forcing baby clamp100 out of engagement with shelves 66, 68. The baby is then left with anaesthetically pleasing koala bear on its navel. Thus, the clamping andcutting of the umbilical cord 164 and the separation of the baby clamp100 from the cutter 10 are easily accomplished with one hand of theuser. Preferably, cutter 10 and baby clamp 100 are placed as close aspossible to the baby before the cutting process is begun so that babyclamp 100 will be essentially adjacent the baby's tummy after theprocess is completed. Cutter 10 remains clamped to cord 164, whichpreserves the blood within cord 164 to be sent to the laboratory withthe placenta (not shown) for any testing that may be necessary.Ultimately, cutter 10 is discarded along with cord 164 and the placenta.

The preferred embodiment shown in the drawings is designed primarily forright-handed use. It will be apparent to those skilled in the art thatcutter 10 and removable baby clamp 100 may be made in the mirror imageof that shown in the accompanying drawings for left-handed use. However,the present inventors have found that the configuration shown in thedrawings is generally preferred by both right-handed and left-handedusers.

Preferably, cutter 10 and baby clamp 100 are provided pre-assembled inthe open position within a sterile package. Although the primary use ofbaby clamp 100 is in conjunction with cutter 10 as described above, babyclamp 100 may also be used to clamp an umbilical cord separate fromcutter 10. Additionally, as shown in FIG. 21, the present invention maycomprise a cutter 200 with two removable clamps 100 and 210, one on eachend of shells 212 and 214. After cutter 200 has been used to sever theumbilical cord, both clamps 100 and 210 may be removed from cutter 200;clamp 100 remains with the infant, and clamp 210 remains with the cordand placenta.

The removable clamp of this invention may also be made in the likenessof animals other than koala bears and in other non-animal shapes. Forexample, FIGS. 25-27 illustrate an umbilical cord cutter 220 inaccordance with this invention having a circular blade 224 and a pair ofremovable clamps 222 in the shape of a teddy bear head. Similarly, FIGS.28-30 illustrate an umbilical cord cutter 230 in accordance with thisinvention having a circular blade 234 and a pair of removable clamps 232in the shape of a duck head, and FIGS. 31-35 illustrate an umbilicalcord cutter 240 in accordance with this invention having an ellipticalblade 244 and a removable clamp 242 in the shape of an ellipse that maybe made to resemble a mouse (FIG. 33), a cat (FIG. 34), or an owl (FIG.35). Thus, although the preferred shape is that of a koala bear, theremovable clamp of this invention may take on many other shapes.

As shown in FIG. 36, an alternative embodiment of the present inventioncomprises a cutter 250 having hinged shells 252 and 254 with a removableclamp 100 mounted at each end of cutter 250 on shelves 266 and 268. Twoblades 40 and clamps 20 depend from shell 252, and two sets of walls 52depend from shell 254 for supporting an umbilical cord (not shown) andrespectively receiving blades 40 as the cord is cut. Two sets of ridges18, 19 are provided on the interior of shell 254 for respectivelycooperating with clamps 20 to clamp the umbilical cord. Cutter 250 isoperated much like cutter 10 as previously described, and tabs 256, 258are provided for latching shells 252, 254 in cooperation with catches60. After shells 252, 254 are closed and the umbilical cord is severed,one of the removable clamps 100 will remain with the infant, the otherremovable clamp 100 will remain with the placenta, and a relativelyshort section of the umbilical cord (not shown) will remain insidecutter 250 between clamps 20. The section of cord between clamps 20 isthus preserved for blood sampling.

Alternatively, cutter 460 of FIG. 61 may be used to preserve a sectionof cord for blood sampling. In this embodiment, cutter 460 comprisesshells 462 and 464, which are engaged with a removable clamp 100. Twoclamps 20 and 466 and a blade 40 depend from shell 462, and walls 52depend from shell 464 for supporting an umbilical cord (not shown) andreceiving blade 40 as the cord is cut. An opening 468 is provided inshell 464 for access to the cord for blood sampling. Cutter 460 isadvantageous in that it preserves a section of umbilical cord betweenclamps 20 and 466 for blood sampling, but at a reduced cost compared tocutter 250 of FIG. 36 because of the absence of the second blade 40 andthe second removable clamp 100.

FIG. 41 shows another alternative embodiment comprising a cutter 440with a removable clamp 100 at each end but only one blade 40 and one setof cord support walls 52 in between. Cutter 440 comprises hinged shells442 and 444 with shelves 446, 448 for holding removable clamps 100 in amanner similar to previously described embodiments. Cutter 440 isoperated much like cutter 10 as previously described, and tabs 450, 452are provided on shell 442 for latching shells 442, 444 in a closedposition in cooperation with catch 60 which depends from shell 444.Preferably, unlike cutters 10 and 250 described above, cutter 440 doesnot have an internal clamp 20 or cooperating ridges 18, 19. Instead, theremovable clamps 100 clamp the umbilical cord (not shown) on either sideof blade 40, and no portion of the umbilical cord is left in cutter 440after the cut is made. As a result, cutter 440 is more easily disposedof because no section of cord remains inside cutter 440 to decay.Although both removable clamps 100 are shown having facial indicia, theremovable clamp on the mother end of cutter 440 need not have suchfacial indicia because aesthetics are not as important for the clamp onthe mother end. Also, an openable clamp such as those shown in FIGS.53-60 is preferable for use on the mother end of cutter 440 to helpfacilitate draining of blood from the placenta.

Referring to FIG. 37, still another alternative cutter 270 compriseshinged shells 12 and 14 with a removable clamp 100 as described abovefor cutter 10 (blade 40 and other internal features not shown), exceptthat shell 14 has a blood collection port 272 in liquid communicationwith the trough 58 between walls 52 of the cutting support. It will beappreciated that cutter 270 is shown in an upside down position and thatcord blood will collect in trough 58 as the umbilical cord is cut.Trough 58 thus serves as a blood collection reservoir. Port 272preferably comprises a Luer connector or some other suitable needlelessfitting to allow extraction of blood from cutter 270 with an extractiondevice 278, such as a Luer syringe or other suitable blood extractiondevice. However, port 272 may comprise a simple gated orifice thatallows needle or needleless access to the blood in trough 58 from theoutside of cutter 270 but does not allow blood to escape whenundisturbed. Examples of suitable gated orifices may include ball valvesand flapper valves. As shown in FIGS. 37 and 38, in lieu of or inaddition to port 272, a series of holes 274 may be provided in shell 14of cutter 270 to allow access to umbilical cord 164 with a needle 282and syringe 280. As shown in FIG. 37, arrows 276 or other suitableindicia may be provided on shell 14 to highlight holes 274. As shown inFIG. 38, the series of spaced apart holes 274 is preferable to allowaccess to cord 164 regardless of the position cord 164 may assume whenclamped between clamp 20 and ridges 18. Port 272 and holes 274 thusallow sampling of the cord blood for later analysis.

FIG. 39 shows still another alternative cutter 296 having hinged shells284 and 286. Similar to cutter 10 described above, a blade 40 is mountedon the interior of shell 284, and cord support walls 52 depend from theinterior of shell 286 for cooperation with blade 40. Likewise, aninternal clamp 20 depends from shell 284 for clamping the umbilical cord(not shown) in cooperation with ridges 18 and 19 on the interior ofshell 286. Tabs 22 and 24 depend from clamp 20 for cooperation withcatch 60 to latch cutter 296 in a closed position. Instead of aremovable clamp, however, cutter 296 preferably has a self-winding band290 held in place by catches 292 and 294 when cutter 296 is in an openposition. As cutter 296 is closed, band 290 releases from catches 292and 294 and wraps itself around the umbilical cord 164 as shown oninfant 165 in FIG. 40. Band 290 may be made from any suitable biasedmaterial, such as spring steel, nylon polymer, or a composite materialas is typically found in a “slap” bracelet having a lateral concavitywhich, when broken, causes longitudinal curling. Although band 290 isshown with multiple turns about the umbilical cord 164 in FIG. 40,sufficient constricting action could be accomplished with only one turnor more than one turn, depending on various factors such as the strengthof the bias of band 290, the length of band 290, and the radialstiffness of cord 164. Alternatively, band 290 may comprise aplastically deformable material that is forcibly deformed about cord 164in order to constrict cord 164.

FIG. 42 shows an alternative cutter 300 similar to cutter 10 describedabove but having a blood collection reservoir 304 disposed within a slot302 in shell 14 between walls 52 of the cord support. A removable clamp100 is engaged at the baby end of cutter 300. As shown in FIGS. 43 and44, blood collection reservoir 304 preferably has several bloodcollection compartments 310, 312, 314, 316, 318 formed by walls 320,322, 324, 326, 328, 330, 332, 334 and outer surface 308, which ispreferably contoured to match the outer surface of shell 14. Edges 306of walls 320 and 322 are preferably V-shaped to match walls 52 of thecutting support, and internal walls 328, 330, 332, 334 are preferablyterminated below the level of edges 306 to allow blade 40 (not shown) topass beneath edges 306 in order to completely sever the umbilical cord.It will be appreciated that reservoir 304 is shown in an upside downposition in FIG. 43. The interior surfaces of compartments 310, 312,314, 316, 318 are preferably coated with an anticoagulant substance (notshown), such as EDTA, and/or another suitable diagnostic substance forproducing a desired reaction with blood in order to indicate aparticular characteristic of the blood. As the cord is cut, blood willdrain down into compartments 310, 312, 314, 316, 318 and react with thediagnostic substance. Preferably, reservoir 304 is made of a transparentpolycarbonate material so that, as a result of the blood reaction, achange in color is viewable from the exterior of cutter 300. Reservoir304 thus provides immediate delivery room diagnostics of blood typeand/or other blood conditions, which is a tremendous advantage for earlydetection of blood diseases or other disorders. Reservoir 304 ispreferably removable from cutter 300 for sending to a lab for furtheranalysis. However, reservoir 304 may be permanently installed orintegral to cutter 300, and walls 320 and 322 of reservoir 304 may serveas the cutting support, replacing walls 52.

As shown in FIGS. 50 and 51, an alternative blood collection reservoir344 may have a single interior compartment 354 bounding by walls 350,352, 356, 358 rather than multiple compartments. Outer surface 346 ofreservoir 344 is preferably contoured to match the contour of shell 14of cutter 300. A strip of diagnostic paper 348 may be installed in thebottom of compartment 354 (it being appreciated that reservoir 344 isshown in an upside down position in FIG. 50). As the cord is cut andblood drains into compartment 354 and contacts diagnostic paper 348,diagnostic paper 348 will undergo some change indicative of a conditionof the blood as is known in the art. Examples of such change may includea change in color or the appearance of a letter or number or othersymbol similar to the behavior of diagnostic paper typically used inconnection with known antigen antibody assays, such as pregnancy testsor strep screens, for instance. Aside from indicating blood type,suitable diagnostic paper may be used to indicate the presence orabsence of various other diseases, such as hepatitis, HIV, or syphilis,as is known in the art. Like reservoir 304, reservoir 344 is preferablymade of a transparent polycarbonate material such that the color changeis viewable from the exterior of cutter 300 in order to provideimmediate delivery room diagnostics of blood type and/or other bloodconditions. Reservoir 344 is preferably removable from cutter 300 forsending to a lab for further analysis. However, reservoir 344 may bepermanently installed or integral to cutter 300, and walls 350 and 352of reservoir 344 may serve as the cutting support, replacing walls 52.

Referring to FIGS. 45 and 46, another alternative blood collectionreservoir 304 a is shown. In this embodiment, reservoir 304 a abutswalls 52 a of the cutting support along line 325. Reservoir 304 apreferably comprises internal compartments 310 a, 312 _(a), 314 a, 316a, 318 a bounded by walls 320 a, 322 a, 324 a, 326 a, 328 a, 330 a, 332a, 334 a. A strip of diagnostic paper 348 is preferably placed in thebottom of each of the compartments 310 a, 312 a, 314 a, 316 a, 318 a,which are provided with access ports 311, 313, 315, 317, 319,respectively, through outer surface 308. After the blood drains downinto compartments 310 a, 312 a, 314 a, 316 a, 318 a and contactsdiagnostic paper 348, ports 311, 313, 315, 317, 319 allow a user toinsert a further diagnostic material, such as an anti-serum for bloodtyping. Reservoir 304 a is preferably removable from cutter 300 forsending to a lab for further analysis. However, reservoir 304 a may bepermanently installed or integral to cutter 300.

Referring to FIGS. 47-49, another alternative cutter 360 is shown havinga removable clamp 100 at each end. Shell 364 of cutter 360 has a slot366 in which a strip of diagnostic paper 348 is disposed. As anumbilical cord is cut, blood drains down into trough 58 between walls 52and proceeds through holes 368 and contacts diagnostic paper 348. Holes362 in shell 364 allow access to diagnostic paper 348 from the exteriorof cutter 360. Holes 362 allow insertion of additional diagnosticmaterial, such as anti-serum for blood typing.

Referring to FIG. 52, another alternative cutter 370 is shown having acapillary conduit 372 which is in liquid communication with trough 58between walls 52. Capillary conduit 372 thus allows access to umbilicalcord blood for sampling purposes by capillary flow from trough 58.Capillary conduit 372 may be removable from cutter 370, if desired, ormay be integral to or permanently affixed to cutter 370. Althoughcapillary conduit 372 is shown as a tube, capillary conduit 372 maycomprise a groove, slit, or other suitable conduit that providescapillary flow of blood. The interior of capillary conduit 372 may becoated with EDTA or another suitable anticoagulant.

Persons skilled in the art will recognize that the various bloodsampling and diagnostic features described herein may be combined withthe various cutters described herein in any desirable combination. Forexample, although FIG. 37 depicts a cutter 270 with a single removableclamp 100 and a port 272 and holes 274, port 272 and/or holes 274 mayalso be used in connection with other cutters having two removableclamps, such as cutter 250 of FIG. 36 or cutter 440 of FIG. 41, or noremovable clamps, such as cutter 296 of FIG. 39. As another example, acapillary conduit such as capillary conduit 372 shown with cutter 370 ofFIG. 52 may be used in connection with any other cutter describedherein. Similarly, the various blood collection reservoirs andassociated holes, ports, and diagnostic paper features described inFIGS. 42-51 may be used in connection with any of the cutters describedherein. The foregoing examples of feature combinations are by way ofexample only and should not be construed as limiting the presentinvention.

FIGS. 53 and 54 illustrate an alternative removable clamp 380 for use inconnection with the cutters of the present invention. Similar toremovable clamp 100 described above, clamp 380 has a clamp body 388 anda strap 390 connected by hinge 392. Clamp 380, however, has an openableclosure 386 so that clamp 380 may be opened if desired. It may bedesirable to open clamp 380 for purposes such as draining blood from theumbilical cord. Finger grips 382 and 384 are provided for manualoperation of closure 386, which is preferably a hemostat-like closure.As shown in FIG. 55, an alternative closure 386 a may be oriented in aconfiguration that is rotated 90 degrees, for example, from that shownin FIGS. 53 and 54.

Referring to FIGS. 56 and 57, another alternative removable clamp 400 isshown having a clamp body 402 and strap 404 connected by hinge 406.Instead of a hemostat-like closure, clamp 400 has a snap-in closurecomprising nibs 412 which cooperate with recesses 410. Squeezing fingergrips 408 with sufficient force will cause nibs 412 to release fromrecesses 410 in order to open clamp 400. Although clamp 400 is shownwith the finger grips 408 and nibs 412 on strap 404 and the recesses 410on body 402, it will be understood that the configuration may bereversed with the finger grips 408 and nibs 412 on body 402 and therecesses 410 on strap 404.

Referring to FIGS. 58-60, another alternative removable clamp 420 isshown having a body 422 and strap 424 connected by hinge 426. Clamp 420has an openable closure comprising a nib 430 which cooperates with arecess 432 to close clamp 420. A tab 428 depends from body 422 such thatpressing tab 428 toward body 422 causes nib 430 to release from recess432 in order to open clamp 420. Again, it will be understood thatalthough nib 430 and tab 418 are shown on body 422 and recess 432 isshown in strap 424, the configuration may be reversed with nib 430 andtab 428 on strap 424 and recess 432 on body 422.

To aid in the identification of infants in multi-infant births, thecutter and removable clamp(s) used for each respective infant may becolor coordinated, with a different color being used for each infant.For example, in a birth of twins, one cutter and its associatedremovable clamp(s) may be blue, and the other cutter and its associatedremovable clamp(s) may be red. Color coordination of the cutter andremovable clamp(s) of the present invention for each respective infantallows delivery personnel easily to keep track of which cord andplacenta is associated with each infant without any need for marking orother identification before cutting. This color-coded system greatlyimproves the efficiency of the delivery process and thus reduces therisk of complications. Before the present invention, the averagedelivery time of each infant in a multi-infant birth was about twominutes. Thus, for a birth of sextuplets using conventional multi-infantdelivery methods, the total delivery time would be about twelve minutes.Using color-coordinated clamps and cutters of the present invention, thefirst named inventor herein was able to deliver an entire group ofsextuplets in about two minutes and four seconds total, which representsa reduction in delivery time of approximately 83%.

As mentioned above, the cutters and removable clamps of the presentinvention are preferably made of a translucent polycarbonate material.For purposes of transparency of the cutter shells and/or the bloodcollection reservoirs in order to observe diagnostic color changes asdescribed herein, the present inventors have found that Makrolon™RX-2530polycarbonate material (1118 tint, product code J4351118) available fromBayer Corporation works quite well, although other suitable materialsmay also be used. For purposes of color coordination of a cutter and itsassociated removable clamp(s) as described herein, the present inventorshave found that the Colorcomp™D-1000 series of polycarbonate materials(product code 732-000-493) available from LNP Engineering Plastics, Inc.works quite well, and more specifically the following formulations: HCYL3-894 TP; HC BL5-984-1 TP; HC GN4-121-1 TP; HC RD1-044-1 TP; HCRD1-312-1 TP; and HC OR2-645 TP. Again, however, other suitablematerials may also be used.

Aside from or in addition to color coordination, it should be understoodthat a similar benefit may be obtained by using other suitablecoordinated identifying attributes for each cutter and its associatedremovable clamp(s). For example, each cutter and its associatedremovable clamp(s) may be identified with like numbers, letters,symbols, bar codes, or other indicia, which are preferably incorporatedinto the cutters and removable clamps at the time of manufacture, suchas by molding, etching, embossing, application of stickers, or othersuitable means. For instance, the first cutter and its associatedremovable clamp(s) may bear the numeral “1,” the second cutter and itsassociated removable clamp(s) may bear the numeral “2,” the third cutterand its associated removable clamp(s) may bear the numeral “3,” and soon. Alternatively, the first cutter and its associated removableclamp(s) may bear the letter “A,” the second cutter and its associatedremovable clamp(s) may bear the letter “B,” the third cutter and itsassociated removable clamp(s) may bear the letter “C,” and so on. Itshould be clear that a multitude of different coordinated identifyingindicia may be used on the respective cutters and removable clamps forsuch purposes, and all such possibilities are intended to be covered bythe claims of the present invention.

Although the foregoing specific details describe a preferred embodimentof this invention, persons reasonably skilled in the art will recognizethat various changes may be made in the details of this inventionwithout departing from the spirit and scope of the invention as definedin the appended claims. Therefore, it should be understood that thisinvention is not to be limited to the specific details shown anddescribed herein.

1. A device for clamping and cutting an umbilical cord, said devicecomprising: a cutter having a first shell and a second shell movablyconnected to said first shell; at least one cutting support dependingfrom said second shell; at least one blade depending from said firstshell for severing the umbilical cord in cooperation with said at leastone cutting support; a first clamping member for compressing theumbilical cord on a first side of said at least one blade in cooperationwith said first and second shells; a second clamping member forcompressing the umbilical cord on a second side of said at least oneblade in cooperation with said first and second shells; wherein at leastone of said first and second clamping members comprises a removableclamp that is engageable with and removable from said first and secondshells; and a blood collection reservoir.
 2. The device of claim 1further comprising a port for providing access to said blood collectionreservoir from outside said device.
 3. The device of claim 2 whereinsaid port comprises a Luer connector.
 4. The device of claim 1 whereinsaid blood collection reservoir is at least partially formed by said atleast one cutting support.
 5. The device of claim 1 wherein said bloodcollection reservoir is removable from said device.
 6. The device ofclaim 1 wherein said blood collection reservoir comprises a plurality ofcompartments.
 7. The device of claim 1 wherein said blood collectionreservoir comprises at least one surface coated with a diagnosticsubstance that reacts with blood.
 8. The device of claim 1 wherein saidblood collection reservoir comprises a diagnostic paper sensitive toblood.
 9. The device of claim 1 further comprising a capillary conduitin liquid communication with said blood collection reservoir, saidcapillary conduit being accessible from outside said device.
 10. Adevice for clamping and cutting an umbilical cord, said devicecomprising: a cutter having a first shell and a second shell movablyconnected to said first shell; at least one cutting support dependingfrom said second shell; at least one blade depending from said firstshell for severing the umbilical cord in cooperation with said at leastone cutting support; a first clamping member for compressing theumbilical cord on a first side of said at least one blade in cooperationwith said first and second shells; a second clamping member forcompressing the umbilical cord on a second side of said at least oneblade in cooperation with said first and second shells; wherein at leastone of said first and second clamping members comprises a removableclamp that is engageable with and removable from said first and secondshells; and wherein at least one of said first and second shellscomprises at least one hole for providing needle access to the umbilicalcord.
 11. The device of claim 10 wherein said cutter and said removableclamp each comprises at least one coordinated identifier.
 12. The deviceof claim 11 wherein said at least one coordinated identifier comprises acolor.
 13. The device of claim 11 wherein said at least one coordinatedidentifier comprises a number.
 14. The device of claim 11 wherein saidat least one coordinated identifier comprises a letter.
 15. The deviceof claim 10 wherein said device comprises two removable clamps, each ofsaid two removable clamps having at least one coordinated identifier.16. The device of claim 15 wherein said at least one coordinatedidentifier comprises a color.
 17. The device of claim 15 wherein said atleast one coordinated identifier comprises a number.
 18. The device ofclaim 15 wherein said at least one coordinated identifier comprises aletter.